ImmuneOnco Biopharmaceuticals (Shanghai) Inc. announce that the Group has received approval from the National Medical Products Administration of the People's Republic of China for the protocol of the Phase III clinical trial of IMM01 (Timdarpacept) in combination with tislelizumab, targeting relapsed or refractory (R/R) classical Hodgkin lymphoma (cHL) patients who relapsed or progressed after the treatment of programmed cell death protein 1 (PD-1) inhibitors in April 2024. IMM01 (Timdarpacept), the Group's core product, is an innovative molecule targeting cluster of differentiation 47 (CD47). It is the first SIRP-Fc fusion protein to enter into clinical stage in China.

IMM01 (Timdarpacept) designed with immunoglobulin G1 (IgG1) Fc can fully activate macrophages via a dual mechanism -- simultaneously blocking the "don't eat me" signal by disrupting CD47/SIRP interaction and delivering the "eat me" signal through the engagement of activating Fc-gamma (Fc) receptors on macrophages. Furthermore, the CD47-binding domain of IMM01 (Timdarpacept) was specifically engineered to avoid human red blood cell (RBC) binding. With the differentiated molecule design, IMM01 (Timdarpacept) has achieved a favorable safety profile and demonstrated its ability to activate macrophages.

The Group owns the global intellectual property rights and commercial rights of IMM01 (Timdarpacept). As of the date of this announcement, in relation to IMM01 (Timdarpacept), the Group owned one patent family, which includes issued patents in China, the United States, Japan and the European Union.